Heartburn Drug to Be Taken Off Market -- Linked to 80 Deaths

Sheryl Gay Stolberg, New York Times

Published
4:00 am PST, Friday, March 24, 2000

2000-03-24 04:00:00 PDT Washington -- The manufacturer of Propulsid, a medication for severe heartburn that has been linked to 80 deaths, said yesterday it will withdraw the drug from pharmacies this summer and instead distribute it free to a limited number of patients for whom all other medicines have failed.

The action by Janssen Pharmaceutica of Titusville, N.J., a holding of Johnson & Johnson, taken with the approval of the Food and Drug Administration, comes on the heels of the withdrawal of another prescription drug, Rezulin, a diabetes medication linked to 63 deaths from liver failure. On Tuesday the FDA ordered it off the market.

The FDA has known since 1994 that Propulsid could cause fatal heart rhythm disturbances in people with cardiovascular disease, but left the drug on the market because it believed the benefits outweighed the risks.

But that assessment was changing, officials said. The FDA had scheduled for April 12 a meeting of a panel of experts who were to discuss Propulsid, including proposals to ban or severely restrict its use.

Under the agreement between the agency and the company, Propulsid, which had $950 million in sales last year, will be marketed until mid-July, to give patients and doctors time to switch to alternative therapies. After that, doctors who want to prescribe the drug will be required to document that other therapies have failed and that their patients do not have conditions or take other medications that would make the Propulsid dangerous.

Propulsid, whose chemical name is cisapride, was approved in 1993 for patients with heartburn. Within a year of its approval, the FDA began receiving reports of injuries and deaths. As of December 31, the agency said, Propulsid had been associated with 341 reports of heart rhythm abnormalities, including the 80 deaths.

The agency had issued new warnings for the drug and changed the label five times, most recently in January. Greg Panico, a spokesman for Janssen, said the company sponsored educational seminars for doctors and pharmacists.

The FDA allowed Propulsid to remain on the market, despite the injuries and deaths, because the only other drug that worked the same way caused serious, and sometimes permanent, neurological damage.

But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group and a frequent critic of the FDA, said Propulsid should have been taken off the market long ago. He described the drug as "a serious public health hazard," and said the agency had wrongly concluded that it could "fix the safety problem" by changing the label.

Roughly 30 million patients have taken Propulsid since it came on the market, although only about 300,000 patients take the drug today.